Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-17 @ 9:49 AM
Study NCT ID:
NCT02870595
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2016-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain associated with injection of lidocaine', 'timeFrame': '30 seconds', 'description': 'Subjects will rate pain of injection using a 0-10 VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain, Analgesia']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.', 'detailedDescription': 'Research Question/Hypothesis\n\nThe investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.\n\nObjectives\n\nThe primary objective of this study is to compare the pain rating scale from an exposure group (digit block injection with the aid MVS) and the control group (traditional injection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals between the ages of 18 and 65 who are willing and able to consent and who require the use of local anesthetic digit block to both sides of a finger for the treatment of wounds, injuries, infections, or laceration of the fingers.\n\nExclusion Criteria:\n\n* Allergy to any type of local anesthetic.\n* Inability to Consent.\n* Inability to complete a numeric pain scale.\n* Clinical appearance or clinical evidence of intoxication.\n* Significant compromising conditions such as major trauma and severe respiratory distress.'}, 'identificationModule': {'nctId': 'NCT02870595', 'briefTitle': 'The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Christus Spohn Memorial Medical Center'}, 'officialTitle': 'The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia', 'orgStudyIdInfo': {'id': '14-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Parallel lidocaine injection', 'description': 'Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.', 'interventionNames': ['Device: Microvibratory Stimulator', "Device: Microvibratory Stimulator'"]}, {'type': 'SHAM_COMPARATOR', 'label': 'Parallel', 'description': 'In the sham comparator, the device will be placed on the skin, but not turned on. Digit block anesthesia will progress in usual fashion as with active comparator, except without the vibratory device engaged.', 'interventionNames': ['Device: Microvibratory Stimulator', "Device: Microvibratory Stimulator'"]}], 'interventions': [{'name': 'Microvibratory Stimulator', 'type': 'DEVICE', 'description': 'Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.', 'armGroupLabels': ['Parallel', 'Parallel lidocaine injection']}, {'name': "Microvibratory Stimulator'", 'type': 'DEVICE', 'description': 'As above, Microvibratory Stimulator will be used as a sham device in parallel group.', 'armGroupLabels': ['Parallel', 'Parallel lidocaine injection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data to be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christus Spohn Memorial Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}